We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01171911
Recruitment Status : Unknown
Verified April 2010 by Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2010
Last Update Posted : July 29, 2010
Information provided by:
Nanjing Medical University

Brief Summary:

Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.

The present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Coronary Artery Disease Drug: Nicardipine , Esmolol Phase 4

Detailed Description:
Blood flow-induced endothelial shear stress has strong effect on endothelial function and development or progression of plaque formation. It is extensively accepted that low and/or oscillating shear stress causes endothelial dysfunction and is one of crucial factors in localizing early atherosclerosis .In contrary, normal and high shear stress is atheroma protective and is involved in compensatory remodeling . Most studies reported that the endothelial shear stress distribution in often idealized geometrical models of human coronary arteries was the subject of numerous investigations , and in these studies it was shown that the geometry of coronary arteries is the main determinant of the observed shear stress distribution. Generally, downstream of a plaque, low shear stress can be expected, Several cardiovascular active drugs have been shown to be cardio-protective for patients with obstructive coronary disease. Of these drugs, calcium channel blocker is one of most prescribed in everyday clinical practice. Ninomiya et al. reported calcium channel blocker was associated with increased coronary diameter and blood fluid with dose-dependent pattern in patients with normal or mild stenotic coronary artery. However, no reports on the dynamic change of endothelial shear stress after calcium channel blocker in -vitron were published so far. As a result, the aim of this study was to evaluate the effect of intra-venous injection of Nicardipine, one calcium channel blocker with shorter half-time, on the re-distribution of endothelial shear stress in patients with acute coronary syndrome and mild stenotic (<50%) coronary artery disease.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nanjing First Hospital, Nanjing Medical University
Study Start Date : October 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Intervention Details:
  • Drug: Nicardipine , Esmolol
    A loading dose of Nicardipine 10mg was at a bolus injected through vein , then continuous trans-venous titration at a speed 1ug/kg was kept. A loading dose of Esmolol 0.5mg/kg/min was at a bolus injected through vein , then continuous trans-venous titration at a speed 0.2mg/kg/min was kept.
    Other Name: Calcium channel blocker

Primary Outcome Measures :
  1. Endothelial shear stress assessed by computational fluid dynamics [ Time Frame: After four minutes ]
    At the peak effect of drug that the mean blood pressure (MBP) reduced by 10% or more, or the heart rate increased by 10-15 bpm.

Secondary Outcome Measures :
  1. Minimal lumen area by intravascular ultrasound [ Time Frame: After four minutes ]
    At the peak effect of drug that the mean blood pressure (MBP) reduced by 10% or more, or the heart rate increased by 10-15 bpm.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of unstable angina and non-Q wave myocardial infarction
  • Age 18-75 yr.
  • Diameter stenosis of coronary artery<70% diameter stenosis by visual estimation
  • Blood pressure >110/70 mmHg
  • Heart rate 60-~100 bpm, No cardiac arrhythmias

Exclusion Criteria:

  • St-elevation myocardial infarction
  • Lower blood pressure(<100/70mmHg)
  • Heart rate <60 or >100 bpm, The presence of cardiac arrhythmias
  • Allergy to study drugs
  • Women in pregnancy
  • Liver dysfunction
  • Creatinine >2.5mg/dl
  • Bleeding stroke within 6 months
  • Left ventricular ejection fraction<30% before maximal medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171911

Layout table for location contacts
Contact: Shaoliang Chen, Director +86-25-52208048 chmengx@126.com

Layout table for location information
China, Jiangsu
Nanjing First Hospital,Nanjing Medical University
Nanjing, Jiangsu, China, 210006
Contact: Shao-liang Chen, Director    +86-25-52208048    chmengx@126.com   
Sponsors and Collaborators
Nanjing Medical University
Layout table for investigator information
Study Chair: Shao-liang Chen, Director Nanjing First Hospital, Nanjing Medical University
Layout table for additonal information
Responsible Party: Shao-Liang Chen/Hospital director, Nanjing First Hospital
ClinicalTrials.gov Identifier: NCT01171911    
Other Study ID Numbers: NJESS20103079
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: April 2010
Keywords provided by Nanjing Medical University:
Endothelial shear stress
Calcium channel blocker
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Membrane Transport Modulators
Vasodilator Agents